Florida Pharmacy Law and Rules: Chapters 465, 64B16, and Administrative Procedures

What is the purpose of the booklet from the Florida Department of Health?

To provide a central location for Florida laws and rules that pharmacy professionals must adhere to.

Which chapter of the Florida Statutes governs the practice of pharmacy?

Chapter 465

What does Chapter 64B16 of the Florida Administrative Code include?

The rules promulgated by the Board of Pharmacy.

What is the role of the Board of Pharmacy according to Chapter 465?

To promulgate rules to further define the mandates of the law.

What is the short title of Chapter 465?

The Florida Pharmacy Act.

What is the legislative intent behind Chapter 465?

To ensure that every pharmacist and pharmacy meets minimum requirements for safe practice.

What does the term 'Administration' mean in the context of Chapter 465?

The obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient.

What is the definition of 'Dispense' according to Chapter 465?

The transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer.

What is required of a pharmacist before dispensing a medicinal drug?

To interpret and assess the prescription order for potential adverse reactions and provide counseling if necessary.

What is a 'Consultant pharmacist' as defined in Chapter 465?

A pharmacist licensed and certified as a consultant pharmacist pursuant to s. 465.0125.

What does 'Data communication device' refer to in the context of pharmacy regulations?

An electronic device that receives and transmits electronic information.

What is the requirement for community pharmacies regarding controlled substances?

A community pharmacy permit is required to dispense Schedule II or Schedule III controlled substances.

What does Chapter 465 say about violations and penalties?

It outlines the consequences for violations of pharmacy practice regulations.

What is the purpose of the Board of Pharmacy's disciplinary guidelines?

To provide a framework for handling violations and ensuring compliance with pharmacy laws.

What is required for the renewal of a pharmacy license according to Chapter 465?

Pharmacists must meet continuing professional pharmaceutical education requirements.

What does Chapter 465 state about the registration of pharmacy interns?

It includes provisions for the registration process of pharmacy interns.

What are the general requirements for pharmacies as per Chapter 465?

Pharmacies must meet specific operational and regulatory standards to maintain their permits.

What is the role of the Department of Health in relation to the Board of Pharmacy?

The Department oversees the implementation of health-related statutes, including those governing pharmacy practice.

What does the term 'Violations and penalties' encompass in pharmacy regulations?

It includes actions that can lead to disciplinary measures against pharmacists or pharmacies for non-compliance.

What is required for a pharmacist to reactivate their license?

They must fulfill continuing education requirements as specified in Chapter 465.

What does Chapter 465 say about the dispensing of medicinal drugs pursuant to a facsimile of a prescription?

It outlines the conditions under which a facsimile prescription can be used for dispensing.

What is an 'institutional formulary system'?

A method for evaluating, appraising, and selecting medicinal drugs deemed most useful for patient care by medical staff.

What are 'medicinal drugs'?

Substances or preparations known as 'prescription' or 'legend' drugs that require a prescription for dispensing.

Define 'patent or proprietary preparation'.

A medicine sold to the public in its original package by the manufacturer or distributor, not misbranded under Florida law.

Who is considered a 'pharmacist'?

A person licensed to practice the profession of pharmacy.

What is a 'community pharmacy'?

Any location where medicinal drugs are compounded, dispensed, stored, or sold for outpatient prescriptions.

What constitutes an 'institutional pharmacy'?

Locations in health care institutions like hospitals or nursing homes where medicinal drugs are compounded, dispensed, stored, or sold.

What happens when a Florida licensed pharmacist is not present in a pharmacy?

The pharmacy department is considered closed.

Who is a 'pharmacy intern'?

A person registered in an accredited pharmacy school or a graduate registered with the department.

What is 'centralized prescription filling'?

The filling of a prescription by one pharmacy at the request of another pharmacy, including other pharmacy duties.

Define 'automated pharmacy system'.

A mechanical system that delivers prescription drugs from a licensed pharmacy and maintains related transaction information.

What is a 'central distribution facility' in pharmacy?

A facility under common control with a hospital that may dispense, distribute, compound, or fill prescriptions for medicinal drugs.

How many members are on the Board of Pharmacy?

Nine members.

What qualifications must pharmacist members of the Board of Pharmacy have?

They must be licensed pharmacists, residents of the state, and have practiced pharmacy for at least 4 years.

What is the composition requirement for pharmacist members on the Board of Pharmacy?

Two must practice in community pharmacy, two in institutional pharmacy, and three can be from any practice setting.

What is required of the two non-pharmacist members of the Board of Pharmacy?

They must be residents of the state with no connection to the pharmacy profession.

What is the maximum term length for members of the Board of Pharmacy?

Members serve terms of 4 years.

What authority does the Board of Pharmacy have regarding rules?

The authority to adopt rules to implement the provisions of the chapter conferring duties upon it.

What is required for a person to apply for licensure as a pharmacist?

-They must complete an application form and pay an examination fee, among other requirements.

-At least 18 years old

-Get a degree from an accredited pharmacy school

-2080 hours of internship

-Pass licensure exams

What is the process for obtaining a license by endorsement?

Applicants must meet qualifications, pass the required examination, and provide evidence of practice or training.

What is the continuing education requirement for applicants licensed in another state?

At least 30 hours of board-approved continuing education for the 2 years preceding the application.

What happens if an applicant is under investigation in any jurisdiction?

The department may not issue a license by endorsement until the investigation is complete.

What conditions prevent the issuance of a pharmacy license by endorsement?

A license cannot be issued if it has been suspended or revoked in another state or if the applicant is currently under disciplinary proceedings in another state.

What is the maximum fee for renewing a pharmacy license?

The fee for renewal cannot exceed $250.

What is required for the biennial renewal of a pharmacy license?

The renewal requires a renewal application, verification of compliance with s. 465.009, and payment of the renewal fee.

What is the minimum number of continuing education hours required for pharmacy license renewal?

At least 30 hours of continuing professional pharmaceutical education are required in the two years prior to renewal.

What is the continuing education requirement for a pharmacist certified to administer vaccines?

They must complete a 3-hour course on the safe administration of vaccines and epinephrine autoinjection.

What must a consultant pharmacist do to maintain drug records?

The consultant pharmacist is responsible for maintaining all drug records required by law and establishing safe drug handling procedures.

Under what conditions can a consultant pharmacist order laboratory or clinical testing?

They can order testing for patients in nursing homes or under home health care, only when authorized by a licensed practitioner.

What additional training is required for a consultant pharmacist to order laboratory tests?

They must receive 3 hours of continuing education related to laboratory and clinical testing.

What is the role of the board in the continuing education process for pharmacists?

The board approves courses, sets educational standards, and may create committees for course approval.

What is the purpose of the rules adopted by the board regarding inactive licenses?

To establish application procedures, renewal processes, and reactivation requirements for inactive licenses.

What happens if a pharmacist does not pay the applicable fees for reactivation?

The department will not reactivate the license unless all fees, including biennial renewal or delinquency fees, are paid.

What is the historical context of the pharmacy license regulations?

The regulations have evolved through multiple legislative changes, with history noted in various sections of the law.

What is the primary responsibility of a nuclear pharmacist?

The compounding and dispensing of nuclear pharmaceuticals, maintaining drug records, establishing safe handling procedures, and ensuring compliance with pharmacy rules.

What additional qualifications must a nuclear pharmacist demonstrate?

Completion of additional training as required by the board, in addition to being a licensed pharmacist.

Which facilities are exempt from the nuclear pharmacist requirements?

Hospitals licensed under chapter 395 and their nuclear medicine facilities.

What is required for a person to be registered as a pharmacy intern?

Certification by the board as being enrolled in an accredited intern program or being a graduate of an accredited pharmacy school.

What can lead to the revocation of a pharmacy intern's registration?

Good cause, including grounds for revocation of pharmacists' licenses as enumerated in the chapter.

Who can engage in the practice of pharmacy?

Only licensed pharmacists or pharmacy interns; pharmacy technicians can only perform tasks under the supervision of a licensed pharmacist.

What are the requirements for a pharmacy technician to register?

Must file an application, pay a registration fee, be at least 17 years old, and complete an approved pharmacy technician training program.

What is the maximum registration fee for pharmacy technicians?

Not to exceed $50 biennially.

What continuing education is required for pharmacy technicians?

20 hours biennially, including 4 hours via live presentation and 2 hours related to medication errors and pharmacy law.

What must a pharmacy technician student wear while obtaining practical training?

Identification indicating their student status.

What happens if a pharmacy technician's license has been denied or suspended?

They are not eligible to register as a pharmacy technician.

What constitutes unlawful operation of a pharmacy?

Owning or operating a pharmacy that is not registered or allowing unlicensed individuals to fill or dispense prescriptions.

What is prohibited regarding false statements in pharmacy applications?

Making false or fraudulent statements in applications or statements presented to the board.

What must a pharmacist do if they learn of a controlled substance being obtained unlawfully?

Report it to the sheriff or chief law enforcement agency within 24 hours.

What is the role of the board in pharmacy practice?

To adopt rules necessary for implementing and administering pharmacy regulations.

What must pharmacy technicians do to renew their registration?

Complete required continuing education courses as specified by the board.

What can lead to disciplinary action against a pharmacy technician?

Committing acts that constitute grounds for discipline as outlined in the relevant chapter.

What is the age requirement for pharmacy technician registration?

Must be at least 17 years old.

What is the significance of the term 'direct supervision' in pharmacy practice?

Pharmacy technicians must perform delegated tasks under the direct supervision of a licensed pharmacist.

What is required for a pharmacy technician to be exempt from initial training program requirements?

Having worked a minimum of 1,500 hours under a licensed pharmacist or being certified by an accredited program.

What must be displayed publicly by pharmacy technicians?

Each registration issued by the board.

What is the penalty for operating an unregistered pharmacy?

It is considered unlawful and subject to penalties as specified in the regulations.

What must a pharmacist report if they suspect fraudulent obtaining of controlled substances?

The pharmacist must report it within 24 hours or by the close of business on the next business day.

What information is required in a report of fraudulent obtaining of controlled substances?

A copy of the prescription, a narrative of the transaction, and identification details of the person who presented the prescription.

What is unlawful for anyone other than a licensed pharmacist?

Using the title 'pharmacist' or 'druggist' or leading the public to believe they are engaged in the practice of pharmacy.

What actions are prohibited for unlicensed individuals regarding pharmacy practices?

Displaying signs or taking actions that imply they are compounding, dispensing, or retailing medicinal drugs.

What is required of a person performing pharmacy technician functions?

They must be registered as a pharmacy technician or exempt from registration.

What are the penalties for violating provisions related to pharmacy practices?

Violations can result in a misdemeanor of the first degree or a felony of the third degree, depending on the provision.

What must a pharmacist require before dispensing a controlled substance to an unknown person?

Valid photographic identification or verification of identity.

In what settings does the identification requirement for dispensing controlled substances not apply?

In institutional settings or long-term care facilities.

What constitutes 'proper identification' for purchasing controlled substances?

An identification issued by a state or the Federal Government with the person's photograph, printed name, and signature.

What is a nonresident pharmacy?

A pharmacy located outside the state that ships or delivers medicinal drugs into the state.

What must a nonresident pharmacy disclose to the board?

They must provide their license status, corporate officer information, and compliance with regulatory requests.

What is required for record-keeping by nonresident pharmacies?

Records of medicinal drugs dispensed must be readily retrievable from other business records.

What communication service must nonresident pharmacies provide?

A toll-free telephone service for communication between patients and pharmacists, available at least 40 hours per week.

What is the application process for nonresident pharmacy registration?

Applications must be made on a form provided by the board, which may require additional information.

What can the board do if a nonresident pharmacy fails to comply with regulations?

The board may deny, revoke, suspend registration, or impose fines or reprimands.

What actions can the board take against a nonresident pharmacy for causing serious injury?

The board may deny, revoke, or suspend registration, or fine or reprimand the pharmacy.

What is required for a nonresident pharmacy to advertise its services in a state?

It must be registered pursuant to the relevant section.

What is the role of the prescription department manager in a registered pharmacy?

The manager must be licensed in the state where the pharmacy is located to dispense into that state.

What must an international export pharmacy maintain to operate legally?

An active and unencumbered license or permit to operate in compliance with local laws.

What is necessary for a pharmacy located outside the U.S. to export prescription drugs into a state?

It must hold an international export pharmacy permit.

What documentation is required for an international export pharmacy permit application?

Proof of compliance with local laws, mutual recognition agreements, and details of corporate officers.

What must an applicant attest to when applying for an international export pharmacy permit?

They must confirm understanding of laws governing drug distribution and that products meet safety standards.

What is the maximum time frame for an inspection report to be considered current for permit applications?

The inspection must have been conducted within 6 months for initial permits or within 1 year for renewals.

What happens if an applicant cannot provide a current inspection report?

The department may conduct an onsite inspection or accept a report from an approved entity.